Recruiting
Phase 2

Vulvar Cancer

Sponsor:

University Medical Center Groningen

Code:

NCT05076942

Conditions

Vulvar Cancer

Sentinel Lymph Node

Lymph Node Metastases

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Radiotherapy combined with cisplatin

Cisplatin

Study Details

Brief summary:

Vulvar cancer patients with SN-metastasis > 2mm will receive chemoradiation instead of an inguinofemoral lymphadenectomy.

Conditions

Vulvar Cancer

Sentinel Lymph Node

Lymph Node Metastases

Study ID

NCT05076942

Start date

Jan 1, 2021

Status verified date

Jul, 2023

Completion date

Jan 1, 2029

Anticipated

Primary completion date

Jan 1, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Histological confirmed primary SCC of the vulva
  • T1 tumor, not encroaching urethra/vagina/anus
  • Depth of invasion > 1mm
  • Tumor diameter < 4cm
  • Unifocal tumor
  • No enlarged (>1.5cm) or suspicious inguinofemoral lymph nodes at imaging (CT/MRI/ultrasound)
  • Possibility to obtain informed consent
  • Metastatic sentinel lymph node; size of metastasis > 2mm and / or extracapsular extension, or
  • Metastatic sentinel lymph node: more than 1 SN with metastasis ≤ 2mm
  • Patients are able to understand requirements of study, provide written informed consent and comply with the study and follow-up procedures
  • Adequate bone marrow, renal and liver function:

  • Absolute neutrophil count ≥ 1.5 x 109 /L
  • Platelet count ≥ 100 x 109 /L
  • Creatinine clearance ≥ 40 ml/min measured by the Cockroft Gault formula
  • Total bilirubin < 1.25 x ULN Aspartate transaminase (AST) and alanine transaminase (ALT) ≤ 2.5 x ULN
  • Performance status of 0, 1 or 2 on the Eastern Cooperative Oncology Group (ECOG) Scale (Appendix A)
  • Age 18 years or older
  • Life expectancy of ≥ 12 weeks
  • Written informed consent

Exclusion Criteria:

  • Inoperable tumors and tumors > 4cm
  • Multifocal tumors
  • Tumors with other pathology than squamous cell carcinoma
  • Patients with enlarged / suspicious lymph nodes which are proven metastatic after fine needle aspiration cytology
  • No other carcinomas, other than basal cell carcinomas, within last 5 years
  • History of pelvic radiotherapy
  • History of any infection requiring hospitalization or antibiotics within 2 weeks before enrollment
  • Pregnant female or nursing mother
  • Desire to become pregnant
  • Known brain or spinal cord metastases unless adequately treated (surgery or radiotherapy) with no evidence of progression and neurologically stable off anticonvulsants and steroids
  • Unstable angina, myocardial infarction, cerebrovascular accident, > Class II congestive heart failure according to the New York Heart Association Classification for Congestive Heart Failure (see Appendix B) within 6 months before enrollment

Study Design

Enrollment

157 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Chemoradiation

Inguinofemoral radiotherapy (48-50 Gy in 1.8 Gy daily fractions, with a boost dose to the involved inguinal site for a total equivalent dose of 56 Gy over 5-6 weeks, preferably with simultaneous integrated boost technique) combined with weekly cisplatin 40 mg/m2 intravenously on days 1, 8, 15, 22 and 29

Interventions

Radiotherapy combined with cisplatin

Inguinofemoral radiotherapy combined with weekly cisplatin

Cisplatin

Inguinofemoral radiotherapy combined with weekly cisplatin

Primary outcome measure

  • Groin recurrence rate [ Time Frame: Within first 2 years after primary treatment ]

Central Contacts and Locations

Central contacts

Maaike H Oonk, MD PhD

+31-50-3613000m.h.m.oonk@umcg.nl

Liza Lahaye

eventinbox@umcg.nl

Locations

UC Irvine Health/Chao Family Comprehensive Cancer Center

Recruiting

Orange, California, United States, 92868

Principal Investigator:

Krishnansu Tewari

Mount Sinai Medical Center

Recruiting

Miami Beach, Florida, United States, 33140

Principal Investigator:

Brian Slomovitz

Baystate Medical Center

Recruiting

Springfield, Massachusetts, United States, 01199

Principal Investigator:

Tashanna Myers

Spectrum Health at Butterworth Campus

Recruiting

Grand Rapids, Michigan, United States, 49503

Principal Investigator:

Kathleen Yost

Munson Medical Center

Recruiting

Traverse City, Michigan, United States, 49684

Principal Investigator:

Kathleen Yost

Nebraska Methodist Hospital

Recruiting

Omaha, Nebraska, United States, 68114

Principal Investigator:

Brent Tierney

Women's Cancer Center of Nevada

Recruiting

Las Vegas, Nevada, United States, 89106

Principal Investigator:

Nicola Spirtos

Memorial Sloan Kettering Basking Ridge

Recruiting

Basking Ridge, New Jersey, United States, 07920

Principal Investigator:

Mario Leitao

Memorial Sloan Kettering Monmouth

Recruiting

Middletown, New Jersey, United States, 07748

Principal Investigator:

Mario Leitao

Memorial Sloan Kettering Bergen

Recruiting

Montvale, New Jersey, United States, 07645

Principal Investigator:

Mario Leitao

Memorial Sloan Kettering Commack

Recruiting

Commack, New York, United States, 11725

Principal Investigator:

Mario Leitao

Memorial Sloan Kettering Westchester

Recruiting

Harrison, New York, United States, 10604

Principal Investigator:

Mario Leitao

Memorial Sloan Kettering Cancer Center

Recruiting

New York, New York, United States, 10065

Principal Investigator:

Mario Leitao

Memorial Sloan Kettering Nassau

Recruiting

Uniondale, New York, United States, 11553

Principal Investigator:

Mario Leitao

Duke University Medical Center

Recruiting

Durham, North Carolina, United States, 27710

Principal Investigator:

Diandra Ayala-Peacock

Duke Women's Cancer Care Raleigh

Recruiting

Raleigh, North Carolina, United States, 27607

Principal Investigator:

Daindra Ayala-Peacock

Ohio State University Comprehensive Cancer Center

Recruiting

Columbus, Ohio, United States, 43210

Principal Investigator:

Christa Nagel

ProMedica Flower Hospital

Recruiting

Sylvania, Ohio, United States, 43560

Principal Investigator:

Adam Walter

University of Oklahoma Health Sciences Center

Recruiting

Oklahoma City, Oklahoma, United States, 73104

Principal Investigator:

Laura Holman

Women and Infants Hospital

Recruiting

Providence, Rhode Island, United States, 02905

Principal Investigator:

Paul DiSilvestro

Avera Cancer Institute

Recruiting

Sioux Falls, South Dakota, United States, 57105

Principal Investigator:

David Starks

More Information

Sponsor

University Medical Center Groningen

Last update posted

Aug 1, 2023

Last verified

Jul, 2023

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by University Medical Center Groningen on 2023-08-01.